Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device

Septicemia Clinical Trial

Official title:

A Matched, Open Label Study to Evaluate the Effectiveness of the MMT Initial Specimen Diversion Device in Reducing Blood Culture Contamination When Compared to Laboratory Standard Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02102087
• Other study ID #: MMT1302
• Status: Completed
• Phase: N/A
• First received: March 21, 2014
• Last updated: August 9, 2017
• Start date: July 2014
• Est. completion date: October 2015

Study information

• Verified date: August 2017
• Source: Magnolia Medical Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a matched, open label study to evaluate the Initial Specimen Diversion Device (ISDD) in reducing the contamination rate in blood culture analysis. Blood culture data will be derived from inpatient and/or outpatient settings in a variety of hospital departments (e.g. ER, surgical, medical, etc.). Only samples that are collected via peripheral venipuncture may be included in this study. The ISDD will be compared to current laboratory practices for the collection of blood for culture purposes. Laboratory Standard Procedures (LSP) is defined as collection of venipuncture blood for culture without an initial diversion method to divert and sequester potential blood contaminants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 971
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Adults >19 years old

Exclusion Criteria:

• Not a good candidate for direct-to-media (DTM) technique

Related Conditions & MeSH terms

• Sepsis
• Septicemia

Intervention

Device:
• Initial Specimen Diversion Device (ISDD)

• Lab standard practice (LSP)

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Magnolia Medical Technologies, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Rupp ME, Cavalieri RJ, Marolf C, Lyden E. Reduction in Blood Culture Contamination Through Use of Initial Specimen Diversion Device. Clin Infect Dis. 2017 Apr 3. doi: 10.1093/cid/cix304. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of blood culture contamination when using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP)	Comparison of contamination for each clinical episode. The proportions of discordant contamination episodes will be compared between the Initial Specimen Diversion Device and Lab Standard Practice using McNemar's test.	Baseline
Secondary	Occurrence rate of adverse device effects	As the device under study enhances the blood diversion procedure during blood culture collection, and is part of standard blood collection standards, adverse device effects are not expected as a result of use of this device, but shall be recorded consistent with the adverse event definitions found in 21 CFR 812. As this is a commercially available device, medical device reporting shall be performed in accordance with 21 CFR 803, as applicable.	Baseline